Vaccinia immune globulin, human (intravenous route)

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Studies on this medicine have been done only in adult patients, and there is no known specific information comparing use of vaccinia immune globulin in children with use in other age groups.

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of vaccinia immune globulin in the elderly with use in other age groups.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Vaccinia keratitis—Use is not recommended.

• Hyperviscosity, known or suspected—May increase chance for serious side effects

• Immunoglobulin A (IgA) deficiency—Increased risk for allergic reaction

Incidence unknown

• Fever
• headache
• nausea
• stiff neck or back

Observed postmarketing

• Back, leg or stomach pain
• black, tarry stools
• bleeding gums
• blistering, peeling, loosening of skin
• bluish color of fingernails, lips, skin, palms, or nail beds
• blurred vision
• change in consciousness
• chest pain
• chills
• cold, clammy, pale skin
• confusion
• convulsions
• cough
• coughing that produces a pink frothy sputum
• dark urine
• decreased urination
• diarrhea
• difficulty or labored breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
• fatigue
• general body swelling
• itching
• irregular heartbeats
• joint or muscle pain
• light-colored stools
• loss of appetite
• loss of bladder control
• loss of consciousness
• muscle spasms or jerking of all extremities
• nausea or vomiting
• no blood pressure or pulse
• noisy breathing
• nosebleeds
• not breathing
• pain in chest, groin, or legs, especially the calves
• painful or difficult urination
• red irritated eyes
• red skin lesions, often with a purple center
• severe, sudden headache
• severe weakness or numbness in arm or leg
• shortness of breath
• slow heart rate
• slurred speech
• sore throat
• sores, ulcers, or white spots in mouth or on lips
• stopping of heart
• sudden loss of coordination
• suddenly sweating
• swelling in legs and ankles
• swollen glands
• tightness in chest
• troubled breathing
• unconsciousness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• wheezing
• yellowing of the eyes or skin

More common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• eye disorder
• energy increased
• feeling unusually cold
• feeling hot
• lack or loss of strength
• lip dry
• muscle pain
• shakiness in legs, arms, hands, feet
• shivering
• trembling or shaking of hands or feet